Juniper has received a licence to make unlicensed medicinal products – or ‘Specials’ – but will only produce batches with relatively high volumes to keep clients’ costs down.
As sponsors and CROs continue the inevitable shift away from 100% SDV (source data verification) in line with US FDA and TransCelerate guidance, new risk-based monitoring (RBM) strategies are cropping up in various ways across the industry.
Understanding international regulatory demands, manufacturing standards and overcoming cultural barriers are key for Asian drugmakers looking to enter Western markets, says market access CRO ELC Group.
The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.
Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.
The world’s top pharma and biologics manufacturing and processing companies have come together in New York this week to showcase the latest in equipment and services.
A merger with Mylan would “transform the global generics space” says Teva, which has entered a $40bn bid as an alternative to the recently proposed Mylan-Perrigo deal.
An anti-fungal drug shows potential to treat a range of cancers, according to research from the Repurposing Drugs in Oncology (ReDO) project, but the drugmakers will need a financial incentive to pursue a licence for new indications.
The FDA is releasing draft guidance articulating its current policy of accepting valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices.
CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there.
A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.
Cash-strapped investigator sites seeking new ways to ensure they get paid promptly will find some new forms of relief in a recently formed Site Advocacy Group (SAG) created by INC Research and the Society for Clinical Research Sites (SCRS).
As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage the 1,200 members of its research network to...
Roche’s Ventana Medical Systems will help Astellas find patients likely to be helped by its candidate cancer drug ASP5878 in a deal that could yield a commercial companion diagnostic.
EU-based Iris Pharma, an ophthalmology-focused CRO (contract research organization) and US-based Oculos Clinical Research, a full-service CRO, announced Thursday a strategic alliance that aims to help sponsors conduct more global clinical trials.
Quintiles on Thursday announced the selection of Hospital Italiano of Buenos Aires, Argentina, as the company’s first “Prime Site” in Latin America, adding to the company’s network of investigative sites worldwide.
To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
BASF, Abitec and Gattefossé dominate the solubility excipients market but growing demand for tech to enhance API solubility is creating opportunities for smaller suppliers according to new research.
Full-service CRO (contract research organization) CTI Clinical Trial and Consulting Services is expanding its use of Medidata’s Clinical Cloud platform to improve operational efficiencies, data accessibility and decision-making processes for its clinical...
Competition in the notoriously tight-lipped CRO (contract research organization) and CMO (contract manufacturing organization) industries is getting fiercer as outsourcing picks up, though that hasn’t stopped one Chinese company from revealing who it...
The Ministry of Health of the Russian Federation approved 151 total clinical studies in Q1 of 2015, which is 11% less than the same quarter last year, though by comparison, it’s still 10 times more than India has approved in the same amount of time.
Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.
Recipharm has invested $2m (EUR1.8m) in metal co-ordinated chemistry (MCC) specialist Synthonics in a deal that will also see it help develop the US firm’s range of targeted drug products.
Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.
Looking for a full-on partnership with Pfizer or a no-strings-attached manufacturing deal? Either way prepare for a tough screening process and don't be located too far from an airport.
With the closing of the acquisition of QSI (Quantum Solutions India), Parexel is looking to help serve its clients further in the pharmacovigilance space.
With an eye on early-phase research, AstraZeneca has signed two deals – a five-year agreement to gain access to PatientsLikeMe’s network, and a three-year alliance with the Lead Discovery Center.
CROs (contract research organizations) continue to collaborate with sponsors on more clinical trials in the US, though the largest companies, such as Quintiles, Parexel and PPD, are working on a much larger share of the research as collaborators than...
Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.
Trial participant payment tech firm Greenphire has moved to a new Philadelphia headquarters to add capacity and plans to hire 40 more staff by the end of the year.
A drug candidate which prevents the export of viral RNA in infected cells could lead the way in developing a functional cure for HIV, according to Abivax.
Waltham, Massachusetts-based CRO Parexel has launched three new academic programs in Germany, Japan and the US, designed to prepare students for careers in the biopharma industry.
In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and...
Almac will transfer its custom peptide manufacturing business to a site at the Edinburgh Technopole business park in Scotland’s capital in a £3.5m move designed to expand capacity.
Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.
